Well-known are treatment methods of a range of listed diseases by enteral introduction of certain enzymes; the patent CA 2394856 A1 particularly describes enteral introduction of enzymes which destroy surface proteins, lipids and carbohydrates for treating infectious diseases. This method doesn't provide destruction of deoxyribonucleic acids as one of the basic components of both intercellular matrix of growing microorganisms and purulent detritus masses. That's why this method isn't effective enough for treating infectious diseases.
Well-known is a method of treating diseases associated with inflammation. The method consists in oral use of proteolytic and lipolytic enzymes Bromelain, GB 984464 A. The formulations used according to the described method also don't contain any enzymes which destroy deoxyribonucleic acids. Because of poor therapeutic effectiveness this method isn't used in clinical pharmacology as an independent method but as an auxiliary one (Bromelain: biochemistry, pharmacology and medical use, Maurer H. R., Cell Mol Life Sci 2001 August 58: pp. 1234-45).
Well-known is a method of systemic enzyme therapy (SET) based on application of proteolytic enzymes compositions introduced in high doses orally or as enemas (Wrba, H. & Pecher, O. Enzymes: A Drug of the Future. Ecomed Verlagsgesellschaft AG & Co., 1993).
Well-known are also methods of treating human diseases associated with inflammation based on enteral introduction of enzyme complex which contains glycolytic, proteolytic and lipolytic enzymes as well as enzymes which destroy deoxyribonucleic acid (deoxyribonucleases, DNASes), GB 1005985 A.
The patent GB1005985 A describes a method of inflammatory diseases treatment consisting in oral introduction of enzymes combination, including streptodornase (streptococcal DNASE) and chemical anti-inflammatory substances; the patent indicates that use of proteolytic enzymes obtained from pancreas is preferable; the conclusion is also done that the dose of used enzymes doesn't influence the treatment efficacy.
Among the above known methods of treatment based on enteral use of DNASE enzymes the closest to the claimed one is a method of treatment of wide range of inflammation-associated diseases based on oral introduction of DNASE enzyme by taking Varidase tablets containing complex of streptokinase and streptodornase (DNASES). The treatment method is based on oral introduction of 4-8 Varidase tablets per day for treatment of some inflammation-associated diseases (ROTE LISTE Buch 2004; ISBN 3-87193-286-8, Rote Liste Service GmbH), and was commonly used: Continued marketing of a useless drug (‘Varidase’) in Panama. (Lee D., Lancet 1990 March, pp. 335: 667).
The main drawback of this method is low therapeutic and prophylactic efficacy of both treatment of gastrointestinal tract disorders and treatment of other organs diseases. The reason is lack of enzyme absorption into the system circulation. It is particularly mentioned in the article: Orally and rectally administered streptokinase. Investigation of its absorption and activity; (Oliven A., Gidron E.; Pharmacology, 1981 vol. 22: pp. 135-8).
Well-known is a medical preparation for oral administration (Varidase) containing streptococcal enzymes streptokinase (proteolytic enzyme) and streptodornase-streptococcal deoxyribonuclease. The preparation contains 10000 units of streptokinase and 2500 units of streptodornase in one tablet (ROTE LISTE Buch 2004; ISBN 3-87193-286-8. Rote Liste Service GmbH).
This preparation is selected as the prototype of the claimed medical preparation.
Low efficacy of the preparation became one of the main reasons that Varidase tablets were taken out of production, and their marketing authorizations were, cancelled in many countries around the world, particularly, in USA. One of the arguments was their pharmacological inefficiency (Department of Health and Human Services Food and Drug Administration; Federal Register, Vol. 50, N240; Dec. 13, 1985).